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Trial record 14 of 129 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

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ClinicalTrials.gov Identifier: NCT00606411
Recruitment Status : Recruiting
First Posted : February 4, 2008
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital

Brief Summary:
The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).

Condition or disease Intervention/treatment Phase
Sleep-Related Eating Disorder Drug: Topiramate or Placebo Early Phase 1

Detailed Description:
This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled, parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder (SRED). The primary objective of this study is to investigate the efficacy and safety of topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a disorder that consists of out of control eating during the night with little or no awareness of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that looks exactly like the study drug, but it does not have any active drug in it. Topamax (topiramate) is approved by the U.S. Food and Drug Administration (FDA) as a therapy for epilepsy, but topiramate has not been approved by the FDA for SRED.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Study Start Date : January 2008
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
Drug Information available for: Topiramate

Arm Intervention/treatment
Active Comparator: Topiramate
Study medication arm, 25-300mg of Topiramate
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax

Placebo Comparator: Placebo
Placebo arm of study, 25-300mg of sugar pill
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax




Primary Outcome Measures :
  1. frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ]

Secondary Outcome Measures :
  1. tolerability of topiramate [ Time Frame: every other week for 10 weeks ]
  2. body weight [ Time Frame: every other week for 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18-65
  • Diagnosis of SRED
  • Must be able to swallow capsules and follow instructions

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Other sleep disorders
  • Kidney or Liver disease
  • Night shift workers
  • Previous history of Topiramate or Topamax use for any condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606411


Contacts
Contact: Leslie Mei 617-643-6026 lamei@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John W Winkelman, MD, PhD Massachusetts General Hospital

Responsible Party: John Winkelman, MD, PhD, Associate Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00606411     History of Changes
Other Study ID Numbers: MGH-2008P000662
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by John Winkelman, MD, PhD, Massachusetts General Hospital:
Sleep-Related Eating Disorder
Topiramate
Parasomnia

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents